FDA Newswatch

Food and Drug News for May 20, 2012

Perrigo Announces FDA Final Approval and Launch of OTC Lansoprazole; Watson Confirms Patent Challenge
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 18, 2012. Perrigo Company (Nasdaq: PRGO) announced it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for Lansoprazole capsules (15 mg). Shipments of product to customers have already begun. This new product for the U.S. store ...
BioMedReports - 2012-05-19 02:09:23

Pfizer And Protalix BioTherapeutics Announce FDA Approval Of ELELYSO? taliglucerase alfa For The Treatment Of Gaucher Disease
Pfizer Inc.(NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX) announced that the United States (U.S.) Food and Drug Administration (FDA) approved ELELYSO? (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease. ELELYSO is the first FDA-approved plant cell-based ERT for Gaucher ...
Pharmacy Choice - 2012-05-19 05:39:04

Tulsa Dangerous Drug Injury Lawyer Comments About Potential Propecia Class Action Lawsuits
PRWEB.COM Newswire djp.ga_fill('300x250-Big-Box-PR'); Tulsa,OK (PRWEB) May 19, 2012 Drug injury lawyer Hansen Dirani warned about the potentially dangerous side effects of Propecia, a drug used for treating male baldness. According to the New York Daily News, Propecia may have more possible sexual side effects than previously thought. 'Propecia has been linked to permanent sexual side effects as ...
Digital Journal - 2012-05-19 02:17:28

Aurobindo Pharma receives US FDA approval
India May 19(IM): Aurobindo Pharma has received final approval from the US FDA to manufacture and market Lamivudine and Zidovudine tablets USP 150/300 mg (ANDA 202418) and is ready for launch. Lamivudine and Zidovudine tablets USP 150/300 mg is the generic equivalent of ViiV Healthcare Company's Combivir Tablets USP 150/300 mg and is indicated as part of antiretroviral (ARV) combination therapy ...
Indian Mirror - 2012-05-19 01:19:03

FDA adds bacteria to test indications
A new study finds that a widely used antibiotic, azithromycin, may increase the likelihood of sudden death in adults, especially those who have heart disease or are at high risk for it. The increased odds of death are small, but significant enough that the authors of the study say doctors should consider prescribing a different drug, like amoxicillin, for high-risk patients who need antibiotics. ...
Healthcare Purchasing News - 2012-05-18 12:59:44

bioRASI Comments on FDA Biosimilar Guidance
Related Searches: Development ' bioRASI ' Bio News & Views ' Related Breaking News bioRASI has issued comments to the FDA in connection with the recent Draft Guidelines Relating to the Development of Biosimilar Products. 'bioRASI is pleased that the FDA is making strides towards establishing a domestic approval pathway for these important drugs, which will provide patients with increased access to ...
Contract Pharma - 2012-05-18 09:39:54

FDA Seeks Public Comments on FSMA Progress
Posted in News, Regulatory, Federal Register, Food and Drug Administration (FDA), Food Safety, International, Inspection, Quality, Laboratory Testing, Codex, Science & Research WASHINGTON'The U.S. Food and Drug Administration (FDA) will hold a public Food Safety Modernization Act (FSMA) meeting 'International Capacity Building with Respect to Food Safety" on June 19, 2012, in Washington, D.C. The ...
Food Product Design - 2012-05-18 13:01:48

FDA Bans Korean Molluscan Shellfish
Posted in News, Regulatory, Food and Drug Administration (FDA), Inspection, Shellfish, Food Safety, International, Bacteria, Microbial, Retail, Foodservice, Quality, Frozen / Refrigerated Foods WASHINGTON'The U.S. Food and Drug Administration (FDA) on May 1 banned the import of all fresh or frozen molluscan shellfish, including oysters, clams, mussels and scallops, imported from Korea because they ...
Food Product Design - 2012-05-18 13:01:47

A new cure for cellulite creates bikini season buzz
Just in time for summer, a new treatment promises to cure cellulite "permanently." Photo courtesy: AFP RELAXNEWS/ Dmitriy Shironosov/shutterstock.com (Relaxnews) - Attempting to banish cellulite has often been a frustrating and pricy dilemma for women, with everything from caffeinated creams to vibrating massages promising to smooth dimples. Now, women are shelling out up to $11,000 for a controversial ...
My Sinchew - 2012-05-19 02:41:33

FDA Proposal Aims at Lower Doses for Pediatric X-Ray
No drug matches No condition matches No procedure matches James Brice processing.... May 18, 2012 The realization that 1-size-fits-all radiography can be bad for children has forged a coalition between federal regulators, physicians, physicists, and medical device manufacturers to make medical imaging involving exposure to ionizing radiation safer for young patients. The US Food and Drug Administration ...
Seminars In Reproductive Medicine - 2012-05-18 11:49:49